|Creating the next generation of cancer treatments
June 17, 2010
Arno Therapeutics Announces Dosing of First Patient in a Phase I/IIa Study of AR-42, a broad spectrum histone and non-histone deacetylation inhibitor (pan-DAC)
PARSIPPANY, N.J., June 17, 2010 -- PARSIPPANY, N.J., June 17, 2010 -- Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing oncology therapeutics, today announced the dosing of the first patient in an investigator sponsored Phase I/IIa clinical study of AR-42 (formerly OSU-HDAC42) at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) in adult patients with relapsed or refractory multiple myeloma (MM), chronic lymphocytic leukemia (CLL) or lymphoma.
The primary objective of this Phase I/IIa, open-label, single-agent dose escalation study is to evaluate the safety and tolerability of oral AR-42 by establishing the maximum tolerated dose (MTD). The secondary objectives include characterizing the pharmacokinetics of the compound, evaluating pharmacodynamic changes in patient biomarkers, and assessing preliminary efficacy of AR-42 in the defined patient population. The Phase I/IIa study is anticipated to enroll up to approximately 50 patients in two phases. The first phase is designed to identify the MTD of the drug, and the second phase will further explore the activity at this MTD dose by enrolling 10 patients into each of three MM, CLL, and lymphoma sub-groups. Craig Hofmeister, M.D., a hematologist and oncologist at OSUCCC-James, is the principal investigator for this single-site clinical trial.
"We are extremely pleased to have enrolled the first patient in the AR-42 Phase I/IIa study. We are very proud of our researchers and clinicians, as this is the second molecule invented at OSUCCC to enter clinical trials within a year. We are encouraged by AR-42's preclinical activity, and we feel that this molecule could have meaningful clinical implications," stated Michael Caligiuri, M.D., director of Ohio State’s Comprehensive Cancer Center and chief executive officer of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.
“It is exciting to see this very potent broad class I/IIa HDAC inhibitor enter the clinic for treatment of blood cancers and we look forward to generating meaningful clinical results from this Phase I/IIa study" said John Byrd, M.D., associate director of translational research at the OSUCCC-James and a leukemia specialist. "The enrollment of the first patient in this Phase I/IIa study of AR-42 is a significant achievement for Arno and OSUCCC-James. We believe that AR-42 is an exciting compound that has exhibited greater potency and preclinical efficacy in multiple preclinical tumor models when compared to other agents in the class. We look forward to continued enrollment and the collection of clinical data," stated Arie Belldegrun, M.D., FACS, Chairman of Arno Therapeutics.
AR-42 is an orally available, broad spectrum inhibitor of both histone and non- histone deacetylation proteins (a “pan-DAC”), both of which may be important in cancer progression. In preclinical studies, AR-42 has shown to be a potent agent with activity that has compared favorably to vorinostat (“SAHA,” or Zolinza®) and other deacetylase inhibitors. Additionally, pre-clinical data presented at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition showed that AR-42 potently and selectively inhibits leukemic stem cells in acute myeloid leukemia (AML).
About Arno Therapeutics
Arno Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops and commercializes innovative products for the treatment of cancer patients. Arno is currently enrolling patients in a Phase I clinical study with its lead clinical compound, AR-12, a potentially first-in-class, orally available PDK1 inhibitor that blocks the PI3K/Akt pathway and may also cause cell death through the induction of endoplasmic reticulum stress. In addition to AR-12 and AR-42, Arno is also developing AR-67, a novel, third-generation camptothecin analogue that inhibits Topoisomerase I activity. AR-67 has demonstrated activity and an excellent safety profile in clinical studies as well as improved pharmacokinetic properties when compared to approved second-generation products Hycamtin® (topotecan) and Camptosar® (irinotecan). Arno is currently enrolling patients in two Phase II studies with AR-67. The first is in patients with Myelodysplastic Syndrome (MDS) who have progressed after receiving prior therapies. MDS is a group of pre-leukemic blood disorders marked by abnormal production of blood cells by the bone marrow. The second study is enrolling patients with glioblastoma multiforme (GBM), a highly aggressive form of brain cancer.
For more information on Arno please visit www.arnothera.com
For more information on The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute please visit cancer.osu.edu
David M. Tanen
Arno Therapeutics, Inc.
Forward-Looking Statements: This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding the timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings, as well as our strategy, future operations, outlook, milestones, the success of Arno's product development, future financial position, future financial results, plans and objectives of management, are forward-looking statements. We may not actually achieve these plans, intentions or expectations and Arno cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make. Such factors include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of our product candidates, our ability to finance the development of our product candidates, regulatory risks, and our reliance on third party researchers and other collaborators. Arno is providing this information as of the date of this presentation and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.